EP4190257B1 - Planarer katheter mit überlappenden elektrodenpaaren - Google Patents

Planarer katheter mit überlappenden elektrodenpaaren

Info

Publication number
EP4190257B1
EP4190257B1 EP22207377.7A EP22207377A EP4190257B1 EP 4190257 B1 EP4190257 B1 EP 4190257B1 EP 22207377 A EP22207377 A EP 22207377A EP 4190257 B1 EP4190257 B1 EP 4190257B1
Authority
EP
European Patent Office
Prior art keywords
electrode
spine
electrodes
spines
end effector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP22207377.7A
Other languages
English (en)
French (fr)
Other versions
EP4190257A2 (de
EP4190257A3 (de
Inventor
Pieter Emmelius Van Niekerk
Andrea Oviedo Buitrago
Henry F. SALAZAR
Shubhayu Basu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biosense Webster Israel Ltd
Original Assignee
Biosense Webster Israel Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biosense Webster Israel Ltd filed Critical Biosense Webster Israel Ltd
Priority to EP25189345.9A priority Critical patent/EP4606306A3/de
Publication of EP4190257A2 publication Critical patent/EP4190257A2/de
Publication of EP4190257A3 publication Critical patent/EP4190257A3/de
Application granted granted Critical
Publication of EP4190257B1 publication Critical patent/EP4190257B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/063—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using impedance measurements
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    • A61B5/25—Bioelectric electrodes therefor
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    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
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    • A61B2018/00595—Cauterization
    • A—HUMAN NECESSITIES
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    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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    • A61B2034/2065—Tracking using image or pattern recognition

Definitions

  • Cardiac arrhythmia such as atrial fibrillation, occurs when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm.
  • Sources of undesired signals can be located in tissue of an atria or a ventricle. Unwanted signals are conducted elsewhere through heart tissue where they can initiate or continue arrhythmia.
  • Procedures for treating arrhythmia include surgically disrupting the origin of the signals causing the arrhythmia, as well as disrupting the conducting pathway for such signals. More recently, it has been found that by mapping the electrical properties of the endocardium and the heart volume, and selectively ablating cardiac tissue by application of energy, it is possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another. The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions.
  • the cross section of the distal portion may include a first opening intersecting the first orthogonal plane and the second orthogonal plane and extending along the longitudinal axis, and six apertures disposed circumferentially about the first opening. Each of the six apertures may be configured to receive a spine.
  • the end effector may be coupled to the distal portion.
  • the end effector may include a first, second, and third loop members. Each of the loop members may include two spines and a connector that connects the two spines.
  • the first, second, and third loop members may be configured such that each connector of the first, second, and third loop members may overlap at a distal vertex.
  • the end effector may be configured to be delivered through vasculature in a collapsed configuration and expand in the heart to a deployed configuration such that in the deployed configuration the loop members are approximately planar.
  • the method may further include deflecting the end effector at an angle relative to the longitudinal axis to contact the one or more first electrode bipoles and one or more second electrode bipoles to the heart tissue, activating one or more second electrode bipoles disposed orthogonally to the longitudinal axis along a respective row of the grid, and receiving, while the plurality of electrodes are in contact with the cardiovascular tissue, electrical potentials from the cardiovascular tissue via the one or more second electrode bipoles.
  • the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 10% of the recited value, e.g. "about 90%” may refer to the range of values from 81% to 99%.
  • the terms "patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
  • tubular and tube are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length.
  • the tubular structure or system is generally illustrated as a substantially right cylindrical structure.
  • the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.
  • FIG. 1A illustrates an example apparatus 10 having an elongated shaft 9, a distal electrode assembly or end effector 100, and a deflection control handle 16.
  • the apparatus 10 can have several design variations while including novel aspects illustrated herein.
  • the apparatus 10 is presented for illustration purposes only and is not intended to be limiting.
  • the proximal portion 12, intermediate section 14, distal portion 14A, and end effector 100 are generally aligned along a longitudinal axis L-L, as shown in FIG. 1A .
  • the intermediate section 14 can be configured to bend to deflect the distal portion 14A and end effector 100 from the longitudinal axis L-L.
  • the useful length of the elongated shaft 9, i.e., that portion of the apparatus 10 that can be inserted into the body excluding the end effector, can vary as desired. Preferably the useful length ranges from about 110 cm to about 120 cm.
  • the length of the intermediate section 14 is a relatively smaller portion of the useful length, and preferably ranges from about 3.5 cm to about 10 cm, more preferably from about 5 cm to about 6.5 cm.
  • Catheter body proximal portion 12 can be attached to the intermediate section 14 as shown and described in FIGS. 2A and 2B of US Patent No. 9,820,664 .
  • a spacer (not shown) can be located within the catheter body 12 between the distal end of the stiffening tube (if provided) and the proximal end of the intermediate section 14.
  • the spacer can provide a transition in flexibility at the junction of the catheter body 12 and intermediate section 14, which can allow this junction to bend smoothly without folding or kinking.
  • a catheter having such a spacer is described in U.S. Pat. No. 5,964,757 .
  • the distal portion 14A of the shaft 9 can be substantially contiguous with the intermediate section 14 such that the intermediate section includes the distal portion 14A; the distal portion being distinguished from the intermediate section 14 by the positioning of one or more (optional) ring electrodes 38R.
  • the distal portion 14A of the shaft 9 can therefore correspond to a distal portion of the intermediate section 14.
  • the connector tubing 46 includes an insert for connection of loop members 1, 2, 3 to provide electrical connection through the intermediate portion 14 of the catheter body.
  • the connector tubing 46 can be affixed to the distal portion 14A of the catheter by glue or the like.
  • the connector tubing 46 can be shaped to house various components such as an electromagnetic position sensor, a puller wire anchor, ring electrodes 38D, 38P, etc.
  • the connector tubing 46 may include an internal lumen configured to house various components, including lead wires configured to connect to ring electrodes 38R, 38D, and 38P.
  • the end effector 100 can be collapsed (compressed toward the longitudinal axis L-L) to fit within a guiding sheath or catheter (not illustrated).
  • the shaft 9 can be pushed distally to move the end effector 100 distally through the guiding sheath.
  • the end effector 100 can be moved to exit a distal end of the guiding sheath via manipulation of the shaft 9 and/or control handle 16.
  • An example of a suitable guiding sheath for this purpose is the Preface Braided Guiding Sheath, commercially available from Biosense Webster, Inc. (Irvine, California, USA).
  • the end effector 100 has first, second and third loop members 1, 2, and 3.
  • Each loop member 1, 2, 3 has two spines 1A, 1B, 2A, 2B, 3A, 3B and a connector 1C, 2C, 3C that connects the two spines of the respective loop member 1, 2, 3.
  • Spines 1A, 1B of a first loop member 1 are connected by a first connector 1C; spines 2A, 2B of a second loop member 2 are connected by a second connector 2C; and spines 3A, 3B of a third loop member 3 are connected by a third connector 3C.
  • the spines 1A, 1B, 2A, 2B, 3A, 3B in the respective pair of spines can be substantially parallel to each other along a majority of their respective lengths when the end effector 100 is expanded in an unconstrained configuration as illustrated in FIG. 1 .
  • all spines in the end effector are parallel to each other along the majority of their respective lengths when the end effector 100 is in the unconstrained configuration.
  • the spines are not necessarily all coplanar as described in greater detail elsewhere herein, for instance in relation to FIGS. 2A through 2D .
  • Each spine 1A, 1B, 2A, 2B, 3A or 3B can have a length ranging between about 5 and 50 mm, preferably about 10 and 35 mm, and more preferably about 28 mm.
  • the parallel portions of each spine 1A, 1B, 2A, 2B, 3A, 3B can be spaced apart from each other by a distance ranging between about 1 mm and 20 mm, preferably between 2 mm and 10 mm, and more preferably about 4 mm.
  • Each spine 1A, 1A, 1B, 2A, 2B, 3A, 3B preferably carries at least eight electrodes per spine member.
  • the end effector preferably includes six spines as illustrated. With eight electrodes on six spines, the end effector 100 includes forty-eight electrodes.
  • a distal electrode 38D and a proximal electrode 38P are positioned near the distal portion 14A of the shaft 9.
  • the electrodes 38D and 38P can be configured to cooperate (e.g. by masking of a portion of one electrode and masking a different portion on the other electrode) to define a referential electrode (an electrode that does not contact tissues).
  • One or more impedance sensing electrodes 38R can be configured to allow for location sensing via impedance location sensing technique, as described in US Patent Nos. 5,944,022 ; 5,983,126 ; and 6,445,864 .
  • each loop member 1, 2, 3 has two spines 1A, 1B, 2A, 2B, 3A, 3B and a connector 1C, 2C, 3C that connects the two spines of the respective loop member 1, 2, 3.
  • Each spine segment 1A, 1B, 2A, 2B, 3A, and 3B have disposed thereon one or more electrodes 37.
  • each spine 1A, 1B, 2A, 2B, 3A, 3B carries at least eight electrodes per spine.
  • the end effector preferably includes 6 spines as illustrated.
  • Each electrode 37 on a respective spine may be separated from an adjacent spine by a distance of Lg1, as measured from a center of a first electrode 37 to a center of an immediately adjacent second electrode 37 (see FIG. 5 ).
  • the distance between each immediately adjacent electrode may be between approximately 1 mm and approximately 2.4 mm, and preferably approximately 1.2 mm.
  • Each electrode 37 may have an electrode width L, which may be between approximately 100 microns to approximately 750 microns, and preferably approximately 500 microns.
  • Loop 2 of end effector 100 may have a length LM1 as measured from the base of end effector 100 to the distal vertex 5.
  • Loop 1 and loop 3 may have a length LM2 as measured from the base of end effector 100 to the distal vertex 5.
  • length LM2 may be greater than length LM1.
  • LM1 may be approximately 17 mm to approximately 24 mm
  • LM2 may be approximately 18 mm to approximately 25 mm.
  • Lateral electrode pairs 37B may consist of laterally adjacent electrodes 37 separated by a distance Lg2. According to some embodiments, end effector may be characterized by the distance Lg2 between lateral electrode pairs 37B that is approximately twice that of distance Lg1 between longitudinal electrode pairs 37A.
  • FIG. 2B illustrates a cross-sectional view through the connector tubing 46.
  • the connector 46 includes a tubular insert 200 that has its center coinciding with the longitudinal axis L-L.
  • Orthogonal planes P4 and P5 are in alignment with the longitudinal axis to define four quadrants in the insert 200.
  • a parallel reference plane P5 is approximately parallel to the end effector 100 illustrated in FIG. 3 , below.
  • An orthogonal reference plane P4 is approximately orthogonal to the parallel reference plane P5 and approximately parallel to the orthogonal axis O-O.
  • Apertures 202, 204, 206, 208, 210, 212 of the insert 200 are sized, positioned, and otherwise configured for insertion of respective end segments 2D, 2E, 3E, 1E, 3D, 1D.
  • Apertures 202, 204, 206, 208, 210, 212 may be disposed circumferentially about a center opening 214.
  • Center opening 214 is disposed at the intersection of orthogonal plane P4 and orthogonal plane P5 for insertion of puller wires, electrical wires, and/or as any other components to and from the end effector 100.
  • center opening 214 may house an irrigation port for providing irrigation to the vasculature or heart of a patient. Components which traverse the apertures 202, 204, 206, 208, 210, 212 and central opening 214 are not illustrated in FIG. 2B for the purposes of illustration.
  • loop members 1, 2 and 3 are arrayed in a non-coplanar unconstrained arrangement, shown in the sectional view of FIG. 2C (as viewed from the proximal end), whereby loop 3 defines a plane P3 (demarcated by spines 3A and 3B with connector 3C) that intersects orthogonal plane P4 with loop 1 having a plane P1 (demarcated by spines 1A and 1B with connector 1C) that intersects both orthogonal planes P4 and P5 and loop 2 having a plane P2 (demarcated by spines 2A and 2B and connector 2C) that intersects orthogonal plane P4 and is substantially parallel to orthogonal plane P5.
  • plane P3 demarcated by spines 3A and 3B with connector 3C
  • P1 demarcated by spines 1A and 1B with connector 1C
  • loop 2 having a plane P2 (demarcated by spines 2A and 2B and connector 2C) that intersects orthogonal plane P4 and is substantially parallel to orthogonal plane P
  • FIG. 2D is a view of the distal end of the end effector looking proximally.
  • loop 1 (defined by spines 1A, 1B and connector 1C) is arrayed to define plane P1 that is contiguous to or extend through spines 1A, 1B and loop 1 whereas spines 2A, 2B and connector 2C of loop 2 are arrayed to define a plane P2 that intersects with plane P1.
  • Spines 3A, 3B and connector 3C of loop 3 are arrayed to define a plane P3 that intersects with both planes P1 and P2.
  • the planes P1, P2, and P3 defined by the respective loops 1, 2 and 3 are configured so that the loops 1, 2 and 3 are not contiguous to or arrayed such that a common plane passes through the loops.
  • planes P1, P2 and P3 are non-parallel and intersect each other.
  • the longitudinal axis L-L may be contiguous to the second plane P2.
  • longitudinal axis L-L may be disposed in between a region bounded by planes P1, P2 and P3.
  • FIGS. 2A through 2D are one example of non-coplanar arrangement of loop members 1, 2, 3 in an end effector. There are numerous possible arrangements non-coplanar arrangements of loop members which can result in an end effector having the general appearance of the illustrated end effector 100.
  • FIG. 3 is an illustration of a side view of the end effector 100.
  • the three loop members 1, 2, 3 overlap at a common distal vertex 5 along the longitudinal axis L-L.
  • the end effector 100 is in an unconstrained configuration as illustrated in FIG. 3 .
  • the loop members 1, 2, 3 are not coplanar with each other.
  • FIG. 3 also illustrates an orthogonal axis O-O orthogonal to the longitudinal axis L-L and approximately orthogonal to the end effector 100.
  • FIG. 4 is an illustration of a standard length end effector according to aspects of the present invention.
  • the standard length end effector has a different geometry as defined by the spacing between adjacent spines of the end effector 100.
  • longitudinal electrode pairs 37A along any given spine 1A, 2A, 3A, 1B, 2B, 3B have a gap length Lg1
  • lateral electrode pairs 37B between two adjacent spines have a gap length Lg2.
  • the shortened end effector 100 may exhibit a lateral gap length Lg2 that is approximately twice the longitudinal gap length Lg1
  • the standard length end effector may exhibit a lateral gap length Lg2 approximately equal to the longitudinal gap length Lg1.
  • Advantages of the shortened end effector design may include increased electrode density, improved maneuverability of the end effector within the heart and vasculature, improved conformance to the tissue while the end effector 100 is in the deployed configuration, and improved usability within patients that have more compact cardiac anatomies.
  • FIG. 5 is an illustration of the shortened length end effector 100.
  • electrodes 37 disposed on spines 1A, 2A, 3A, 1B, 2B, and 3B may define an electrode grid.
  • rows I, II, III, IV, V, and VI define the rows of the electrode grid
  • numbers 1, 2, 3, 4, 5, 6, 7, 8 define the columns of the electrode grid.
  • the electrode grid includes 48 electrodes 37.
  • the electrode grid may be substantially rectangular or square in shape, thereby allowing electrical signals propagating in orthogonal directions (e.g., a first electrical signal propagating along one of rows I-VI and a second electrical signal propagating along one of columns 1-8) to be measured with a high resolution due to the (rectangular or square) grid that end effector 100 provides.
  • shortened end effector may exhibit a lateral gap distance Lg2 that is approximately twice the longitudinal distance Lg1.
  • shortened end effector may provide equidistant electrode spacing by bypassing every other electrode in the longitudinal direction to provide for equidistantly spaced electrode bipoles in both the longitudinal (e.g., along rows I-VI) and the lateral (e.g., along columns 1-8) directions.
  • longitudinal electrode bipole pairs 37A that have a gap distance equivalent to the lateral gap distance Lg2 (e.g., pair 1-3, pair 2-4, pair 3-5, pair 4-6, pair 5-7, and/or pair 6-8 along any given row I-VI).
  • shortened end effector 100 exhibits equidistantly spaced electrode bipole pairs in both the lateral and longitudinal directions while providing a more compact and easier to maneuver end effector for imaging the heart and surrounding vasculature.
  • Closely-spaced electrode bipoles 37 allow for more accurate detection of near field pulmonary vein potential versus far field atrial signals, which is important when treating atrial fibrillation. More specifically, near pulmonary vein potentials are very small signals whereas atrial signals are typically far larger. Accordingly, a physician may encounter difficulty in determining whether a measured potential is due to a small, close potential (e.g., from the pulmonary vein) or a larger, albeit more distant potential (e.g., from the atria).
  • the closely spaced electrode bipoles enabled by the shortened end effector 100 allow an operating physician to more accurately determine whether he is measuring a close signal or a far signal. Accordingly, by providing closely-spaced electrodes, the physician is able to target exactly the locations of myocardial tissue that have pulmonary vein potentials and therefore allows the physician to delivery therapy to the appropriate tissue. Additionally, the closely-spaced electrode electrodes allow the physician to determine the anatomical location of the ostium/ostia based on the measured electrical signal.
  • FIGS. 6A and 6B are illustrations of views of the end effector pressed to a planar surface.
  • the loop members 1, 2, 3 can be pressed to a planar surface S via manipulation of the shaft 9 of the device. More specifically, when the end effector 100 is positioned within a patient, manipulation of the catheter body 12 and the control handle 16 can be used to position the end effector 100 against a surface within a wall of an internal cavity of the patient such internal walls of the heart and/or blood vessels. When the end effector 100 is positioned against the planar surface S, a majority of each length of each spine 1A, 2A, 3A, 1B, 2B, 3B can become contiguous and aligned to the planar surface.
  • each spine 1A, 2A, 3A, 1B, 2B, 3B can become aligned with a majority of each length of the other spines.
  • the surface S need not necessarily be planar in order for the spines 1A, 2A, 3A, 1B, 2B, 3B to become contiguous and aligned to the surface.
  • the end effector 100 may be able to conform to a curved surface, for instance.
  • the connecting segments 1C, 2C, 3C can be stacked on top of the surface S at the distal vertex 5 at the linkage 50.
  • a first connecting segment 1C nearest to the surface S can be separated from the surface S by the linkage 50.
  • a second connecting segment 3C stacked onto the first connecting segment 1C can be separated from the surface S by the linkage 50 and the first connecting segment 1C.
  • a third connecting segment 2C can be separated from the surface S by the linkage 50 and the first and second connecting segments 1C, 3C.
  • each connecting segment 1C, 2C, 3C can be separated from the planar surface S when the majority of each spine 1A, 2A, 3A, 1B, 2B, 3B is pressed to the planar surface.
  • the linkage 50 can be inset into the first connecting segment 1C such that the first connecting segment is substantially contiguous to the planar surface S. In that case, only the second and third connecting segments 3C, 2C are separated from the planar surface S at the distal vertex 5.
  • Proximal segments 1D, 2D, 3D, 1E, 2E, 3E of the loop members 1, 2, 3 can be bent such that at least a portion of each of the proximal segments curves away from the surface S.
  • each spine 1A, 2A, 3A, 1B, 2B, 3B When the majority of each spine 1A, 2A, 3A, 1B, 2B, 3B is pressed to the surface S, at least some of the electrodes 37 on each spine can be in contact with the surface S. In some examples, every electrode 37 on each spine can be in contact with the surface S.
  • each spine 1A, 2A, 3A, 1B, 2B, 3B When the majority of each spine 1A, 2A, 3A, 1B, 2B, 3B is pressed to the surface S, the majority of each respective length of each loop member can become contiguous to the surface S, where the respective length of each loop member includes the length of the respective loop member's spines 1A, 2A, 3A, 1B, 2B, 3B, connectors 1C, 2C, 3C, and proximal segments 1D, 2D, 3D, 1E, 2E, 3E (distal to the connector tubing 46).
  • FIG. 7A is an illustration depicting electrode spacing and dimensions on the shortened end effector.
  • the electrodes 37 can include one or more pairs of closely-spaced bipolar electrodes 37 which are configured to pick up electrocardiogram signals from tissue.
  • the electrodes 37 of an adjacent longitudinal pair has a separation space gap distance Lg1 therebetween of approximately 1 mm to 200 microns and preferably no greater than about 200 microns.
  • Each electrode 37 has an electrode area Ae and electrode length L.
  • the electrode length can be from about 2 mm to about 0.5 mm.
  • Each electrode 37 preferably has a length of 1 mm to 0.5 mm.
  • the electrodes 37 as illustrated are cylindrical such that the electrode area is calculated as a produce of the circumference C and length L of the electrode.
  • the spine has a diameter D.
  • laterally spaced electrode pairs 37B may have a gap distance Lg2.
  • the lateral gap distance Lg2 may be approximately twice the longitudinal gap distance Lg1.
  • the electrodes 37 need not completely circumscribe the respective loop 1, 2, 3; in which case the electrodes 37 can have a rectangular shape that is rectilinear or arced having a width W such that the electrode area Ae is a produce of the electrode length L and width W, the width being the arc length when the rectangular shape is arced.
  • a conversion factor CF may be used to determine the appropriate gap distance between the electrodes based on the known area of either one of the pair of electrodes.
  • the conversion factor CF may range from about 2 to 0.1 in the inverse of the same root dimensional unit as the planar area of an electrode.
  • the smallest gap distance Lg1 along the longitudinal axis extending through both electrodes can be determined by applying the conversion factor CF (in the inverse of the same root dimensional unit of the area or mm) to arrive at a gap distance Lg1 of about 100 microns.
  • the conversion factor CF in the inverse of the same root dimensional unit or mm -1
  • the conversion factor CF can be 1.25mm -1 or less, giving the range of the smallest gap distance Lg1 from about 300 microns to about 24 microns.
  • a preferred conversion factor CF is about 0.8 (in the inverse of the same root dimensional unit for the electrode area).
  • FIG. 7B is another illustration of the shortened end effector 100 including a mechanical linkage 50.
  • At least one pair of closely-spaced bipolar microelectrodes 37 is provided on each spine 1A, 2A, 3A, 1B, 2B, 3B in the present example. More particularly, each spine 1A, 2A, 3A, 1B, 2B, 3B carries four pairs of adjacent bipolar microelectrodes 37 corresponding to eight microelectrodes 37 per spine. This number may be varied as desired. As discussed with respect to FIG.
  • the end effector 100 may provide electrode bipoles that bypass every other electrode in the longitudinal direction to provide for equidistantly spaced electrode bipoles in both the longitudinal (e.g., along rows I-VI of FIG. 5 ) and the lateral (e.g., along columns 1-8 of FIG. 5 ) directions.
  • FIG. 5 also illustrates a mechanical linkage 50 coupling connectors 1C, 2C, 3C together in a single connection point. The mechanical linkage 50 functions to maintain a spatially fixed arrangement between the loops 1, 2, 3 at the common distal vertex 5.
  • the second driver module 116 is coupled with field generators 120 via a cable 122.
  • the second driver module 116 is operable to activate field generators 120 to generate an alternating magnetic field around the heart H of the patient PA.
  • the field generators 120 may include coils that generate alternating magnetic fields in a predetermined working volume that contains the heart H.
  • Some versions of the apparatus 10 include a position sense near or within the end effector 100 that is operable to generate signals that are indicative of the position and orientation of end effector 100 within the patient PA.
  • Each position sensor may include a wire coil or a plurality of wire coils (e.g., three orthogonal coils) that are configured to generate electrical signals in response to the presence of an alternating electromagnetic field generated by field generators 120.
  • Other components and techniques that may be used to generate real-time position data associated with end effector 100 may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, and the like.
  • position sensing may be provided in accordance with at least some of the teachings of U.S. Pat. No. 9,480,416 .
  • apparatus 10 may lack a position sensor near the end effector 100.
  • the display 118 is coupled with the processor of console 112 and is operable to render images of patient anatomy. Such images may be based on a set of preoperatively or intraoperatively obtained images (e.g., a CT or MRI scan, 3-D map, etc.). The views of patient anatomy provided through the display 118 may also change dynamically based on signals from the position sensor near the end effector 100.
  • the processor of the console 112 may also drive the display 118 to superimpose the current location of end effector 100 on the images of the patient's anatomy, such as by superimposing an illuminated dot, a crosshair, a graphical representation of end effector 100, or some other form of visual indication.
  • the fluid source 142 can include a bag containing saline or some other suitable irrigation fluid.
  • the conduit 140 can include a flexible tube that is further coupled with a pump 144, which is operable to selectively drive fluid from the fluid source 142 to the irrigation tube 15 of the apparatus 10.
  • a pump 144 which is operable to selectively drive fluid from the fluid source 142 to the irrigation tube 15 of the apparatus 10.
  • the conduit 140, fluid source 142, and pump 144 are omitted entirely.
  • FIG. 9 is a flowchart of an exemplary method of treating a patient utilizing the apparatus according to aspects of the present invention.
  • the method may include moving a distal portion of an elongated shaft (e.g., elongated shaft of FIG. 1 ) and an end effector (e.g., end effector 100) extending distally from the distal portion through a catheter (e.g., catheter 10) and into a heart.
  • a catheter e.g., catheter
  • the elongated shaft may define a longitudinal axis (e.g., longitudinal axis L-L) and the end effector may include a plurality of electrodes (e.g., electrodes 37) that are disposed on a plurality of equidistantly spaced spine members parallel to the longitudinal axis (e.g., spines 1A, 1B, 2A, 2B, 3A, 3B).
  • the plurality of electrodes may be arranged in a grid (e.g., as shown in FIG. 5 ) with the plurality of electrodes forming rows of the grid.
  • the method may include moving the end effector from a distal end of the catheter via manipulation of a proximal portion of the elongated shaft (e.g., control handle 16, as shown in FIG. 1 ).
  • the method may include contacting a plurality of electrodes (e.g., electrodes 37), carried by the end effector (e.g., end effector 100), to heart tissue via manipulation of the proximal portion of the elongated shaft.
  • the method may include activating one or more first electrode bipoles (e.g., electrode bipole 37A) disposed on at least one spine member.
  • the first electrode bipole may consist of two electrodes having at least a third electrode positioned between the two electrodes.
  • a bipole configuration that skips every other electrode on a given spine allows for the shortened end effector 100 to provide a longitudinal gap distance Lg1 approximately equivalent to the lateral gap distance Lg2 of the shortened end effector 100.
  • the method may include activating a first electrode bipole disposed on a first spine member and a second electrode bipole (e.g., lateral bipole 37B) disposed orthogonally to the longitudinal axis along a respective row of the grid.
  • a first electrode bipole disposed on a first spine member and a second electrode bipole (e.g., lateral bipole 37B) disposed orthogonally to the longitudinal axis along a respective row of the grid.
  • the method may include receiving, while the plurality of electrodes are in contact with the heart tissue, electrical potentials via the one or more first electrode bipoles (e.g., longitudinal bipoles 37A).
  • the method may include receiving, while the plurality of electrodes are in contact with the heart tissue, electrical potentials via the one or more second electrode bipoles (e.g., lateral bipoles 37B).

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Claims (16)

  1. Vorrichtung (10), umfassend:
    ein röhrenförmiges Element (9), das einen proximalen Abschnitt und einen distalen Abschnitt umfasst, die eine Längsachse (L-L) definieren, wobei das röhrenförmige Element so konfiguriert ist, dass es am proximalen Abschnitt manipuliert werden kann, um den distalen Abschnitt in einem Herzen eines Patienten zu positionieren, wobei der distale Abschnitt einen Querschnitt aufweist, der um die Längsachse angeordnet ist, wobei der Querschnitt eine erste (P4) und eine zweite (P5) orthogonale Ebene schneidet, die sich entlang der Längsachse erstrecken, wobei der Querschnitt des distalen Abschnitts eine erste Öffnung (214) beinhaltet, die die erste orthogonale Ebene und die zweite orthogonale Ebene schneidet und sich entlang der Längsachse erstreckt;
    sechs Durchbrüche (202, 204, 206, 208, 210, 212), die kreisförmig um die erste Öffnung angeordnet sind, wobei jeder der Durchbrüche zum Empfangen eines Dorns konfiguriert ist; und
    einen Endeffektor (100), der mit dem distalen Abschnitt verbunden ist und ein erstes (1), zweites (2) und drittes (3) Schleifenelement umfasst, wobei jedes der Schleifenelemente zwei Dorne (1A/B, 2A/B, 3A/B) und einen Verbinder (1C, 2C, 3C) umfasst, der die beiden Dorne verbindet, wobei das erste, zweite und dritte Schleifenelement derart konfiguriert sind, dass sich die Verbinder des ersten, zweiten und dritten Schleifenelements an einem distalen Scheitelpunkt (5) überlappen, und wobei der Endeffektor so konfiguriert ist, dass er in kollabierter Konfiguration durch das Gefäßsystem eingeführt wird und sich im Herzen in eine entfaltete Konfiguration ausdehnt, derart dass in der entfalteten Konfiguration jedes der Schleifenelemente eine Ebene definiert.
  2. Vorrichtung nach Anspruch 1, wobei die beiden Dorne des ersten Schleifenelements an nicht benachbarten Öffnungen des Querschnitts des distalen Abschnitts befestigt sind, die beiden Dorne des zweiten Schleifenelements an unmittelbar benachbarten Öffnungen angebracht sind und die beiden Dorne des dritten Schleifenelements an nicht benachbarten Öffnungen des Querschnitts angebracht sind, derart dass das erste und das dritte Schleifenelement das zweite Schleifenelement nicht schneiden.
  3. Vorrichtung nach Anspruch 1, wobei das erste Schleifenelement und das dritte Schleifenelement äußere Schleifen umfassen und das zweite Schleifenelement eine innere Schleife umfasst, derart dass die äußeren Schleifen einander entlang der Längsachse schneiden und die innere Schleife entlang der Längsachse nicht schneiden.
  4. Vorrichtung nach Anspruch 1, wobei vier Durchbrüche auf einer Seite der zweiten orthogonalen Ebene angeordnet sind, wobei drei Durchbrüche auf einer Seite der ersten orthogonalen Ebene angeordnet sind und drei Durchbrüche auf der anderen Seite der ersten orthogonalen Ebene angeordnet sind.
  5. Vorrichtung nach Anspruch 1, wobei sich das zweite Schleifenelement auf einer Seite der zweiten orthogonalen Ebene befindet.
  6. Vorrichtung nach Anspruch 1, wobei die zwei Dorne jedes Schleifenelements sich entlang der Längsachse erstrecken und jeder der beiden Dorne eine Vielzahl von Elektroden (37) umfasst, die mindestens eine erste Elektrode, eine zweite Elektrode und eine dritte Elektrode umfassen, die darauf angeordnet sind.
    wobei jede Elektrode der Vielzahl von Elektroden von einer unmittelbar benachbarten Elektrode auf einem jeweiligen Dorn der beiden Dorne um eine erste Spaltlänge (Lg1) beabstandet ist,
    wobei die erste Elektrode und die dritte Elektrode eines jeweiligen Dorns der beiden Dorne einen ersten Bipol bilden,
    wobei jede jeweilige Elektrode eines ersten Dorns von einer entsprechenden Elektrode eines zweiten Dorns um eine zweite Spaltlänge (Lg2) beabstandet ist, die etwa das Doppelte der ersten Spaltlänge beträgt, und
    jede Elektrode des ersten Dorns mit der entsprechenden Elektrode des zweiten Dorns zweite Bipole bildet.
  7. Vorrichtung nach Anspruch 6, wobei jeder Dorn derart konfiguriert ist, dass in der entfalteten Konfiguration jeder Dorn der beiden Dorne des ersten, zweiten und dritten Schleifenelements ungefähr parallel zueinander verläuft, sodass die Vielzahl von Elektroden derart positioniert ist, dass sie ein Elektrodengitter definieren.
  8. Vorrichtung nach Anspruch 6, wobei die jeweiligen Elektroden des ersten Dorns linear entlang des ersten Dorns beabstandet sind und jeweils überlappende Elektrodenpaare bilden.
  9. Vorrichtung nach Anspruch 6, wobei die erste Spaltlänge zwischen unmittelbar benachbarten Elektroden von der Mitte jeder der unmittelbar benachbarten Elektroden aus gemessen wird, wobei jeder Dorn optional eine Vielzahl von Dornsegmenten umfasst, die jeweils eine Länge aufweisen, die gleich der ersten Spaltlänge abzüglich
    einer Länge einer jeweiligen Elektrode ist, wobei jedes Dornelement acht Elektroden umfasst und ferner optional jede der acht Elektroden eine Elektrodenlänge von ungefähr 100 Mikrometern bis ungefähr 750 Mikrometern aufweist.
  10. Vorrichtung nach Anspruch 6, wobei die erste Spaltlänge eine Länge umfasst, die aus ungefähr 1 Millimeter, ungefähr 1,2 Millimeter und ungefähr 2,4 Millimetern ausgewählt ist.
  11. Vorrichtung nach Anspruch 6, wobei die Vielzahl von Elektroden dazu konfiguriert ist, elektrische Potentiale vom Herzen zu empfangen, wenn sich der Endeffektor in der ausgefahrenen Konfiguration befindet, und/oder Herzgewebe zu abladieren, wenn sich der Endeffektor in der ausgefahrenen Konfiguration befindet.
  12. Vorrichtung nach Anspruch 1, wobei der Endeffektor ein distales und ein proximales Ende aufweist und das distale Ende so konfiguriert ist, dass es in der kollabierten Konfiguration durch das Gefäßsystem eingeführt wird und sich im Herzen in eine entfaltete Konfiguration ausdehnt, der Endeffektor eine Vielzahl von Elektroden (37) umfasst, die auf den Dornen angeordnet sind, wobei die Dorne in gleichem Abstand und parallel zur Längsachse angeordnet sind und die Vielzahl von Elektroden in einem Gitter angeordnet ist,
    wobei die Vielzahl von äquidistant beabstandeten Dornen Spalten des Gitters bilden, so dass innerhalb jeder jeweiligen Spalte die Vielzahl von Elektroden von einer unmittelbar benachbarten Elektrode um eine erste Spaltlänge (Lg1) beabstandet ist,
    wobei die Vielzahl von Elektroden Reihen des Gitters über die Vielzahl von Dornen hinweg bildet, so dass innerhalb jeder jeweiligen Reihe die Vielzahl von Elektroden von einer unmittelbar benachbarten Elektrode um eine zweite Spaltlänge (Lg2) beabstandet ist, die etwa das Doppelte der ersten Spaltlänge beträgt.
  13. Vorrichtung nach Anspruch 12, wobei die Vielzahl von Dornen derart konfiguriert ist, dass sie in der entfalteten Konfiguration etwa parallel zueinander und etwa eben sind, sodass die Vielzahl von Elektroden in dem Gitter derart positioniert ist, dass sie eine Elektrodenanordnung definieren.
  14. Vorrichtung nach Anspruch 12, wobei sie derart konfiguriert ist, dass die Vielzahl von Elektroden eine erste Elektrode, eine zweite Elektrode und eine dritte Elektrode auf jedem Dorn der Vielzahl von Dornen umfasst.
    wobei die erste Elektrode eines ersten Dorns und die dritte Elektrode des ersten Dorns einen ersten Bipol bilden,
    wobei jede Elektrode des ersten Dorns eine Vielzahl von zweiten Bipolen mit einer entsprechenden Elektrode eines zweiten Dorns bildet, die unmittelbar seitlich neben dem ersten Dorn positioniert ist.
  15. Vorrichtung nach Anspruch 12, wobei jede Elektrode der Vielzahl von Elektroden (i) eine Elektrodenlänge von ungefähr 100 Mikrometern bis ungefähr 750 Mikrometern oder (ii) eine Elektrodenlänge von ungefähr 500 Mikrometern aufweist.
  16. Vorrichtung nach Anspruch 12, wobei die erste Spaltlänge eine Länge aufweist, die aus ungefähr 1 Millimeter, ungefähr 1,2 Millimeter und ungefähr 2,4 Millimetern ausgewählt ist.
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CN116135163A (zh) 2023-05-19
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EP4190257A2 (de) 2023-06-07
EP4190257A3 (de) 2023-08-16

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